Askel Healthcare, a Finnish medical technology company pioneering the treatment and repair of focal knee cartilage defects, presented results from its first-in-human Pilot Clinical Trial at the 9th Joint Preservation Congress in Warsaw on June 14-15. The primary endpoint of the trial, safety, was successfully met in all initial ten patients. The trial also provided promising preliminary efficacy data.
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The COPLA® Cartilage implant is a novel biodegradable solution designed to surgically treat knee cartilage damage. Askel Healthcare aims for this implant to become the global standard for first-line surgical knee cartilage repair. A key differentiator of the COPLA® Cartilage implant is its ability to allow immediate, unrestricted full weight-bearing post-surgery. This facilitates faster rehabilitation and a quicker return to activities, as were observed in the Pilot Trial. Early mechanical loading aids cartilage regeneration, contributing to the formation of high-quality tissue, and is essential for long-term positive outcomes.
Key Findings from the Pilot Trial Based on the Interim Report with the first 10 Subjects at the 6-Month Follow-Up:
- Safety: COPLA® Cartilage implant is safe for use in humans with no implant-related complications reported.
- Weight-Bearing: All patients achieved full and unrestricted weight-bearing immediately after surgery and maintained this ability throughout the first six months.
- Clinical Improvements: Significant improvements in knee function and pain levels were observed over six months, with no pain medication needed from six weeks post-surgery onwards.
- Recovery: Physiotherapist evaluations indicated good recovery, with knee movement improved and strength returning to pre-surgery levels within three months. All patients returned to their pre-injury activity levels between six weeks and three months, which was maintained at six months. Patients reported high satisfaction with the surgery, noting an overall improvement in their quality of life.
- Ease of use: The implantation of COPLA® was successful in all surgeries. Tailoring and placement of the implant to the lesion, added on average 15 minutes to the length of surgery. No special instrumentation was needed.
“Cartilage defects are prevalent, particularly among athletes, and existing treatments are often unreliable. The initial results with COPLA® are impressive, showing promise for active patients by enabling early weight-bearing, swift rehabilitation, and a quick return to activities. However, it is important to note that these outcomes are based on a very small patient sample.” stated Dr. Teemu Paatela (MD), Chief Orthopaedic Surgeon and Director of Musculoskeletal Businesses at Terveystalo, Finland’s largest private hospital chain. Dr. Paatela is the Coordinating Principal Investigator in the ongoing COPLA® Pilot Clinical Trial and a member of Askel’s Clinical Advisory Board. He presented the Pilot Trial results at the Warsaw Joint Preservation Congress, which focuses on joint preservation and explores topics related to orthobiology, regenerative medicine, and innovative techniques in orthopedics, bringing together experts and researchers in these fields.
“One of the most rewarding aspects of the Pilot Trial were the comments we received from the patients implanted with COPLA®. Knee pain and movement limitations are very disabling for anyone, but even more for the physically active individuals who were the majority of the population in the Pilot Trial. Hearing their stories about returning to the sports or activities they love without pain or discomfort has been very rewarding.” commented Petra Raatikka, Chief Clinical Officer at Askel Healthcare.
Askel’s strategy involves collaboration with globally renowned orthopedic surgeons and sports medicine specialists in its clinical development. The company has established a prestigious Clinical Advisory Board (CAB) comprising internationally recognised experts in cartilage damage treatment. The CAB is chaired by Swedish professor Mats Brittberg (MD), an orthopedic surgeon and honorary member of the International Cartilage Regeneration and Joint Preservation Society (ICRS), and a leading researcher in knee cartilage repair.
The company will now turn its focus towards an upcoming Pivotal Trial, for which preparations are well underway. Meanwhile, the Pilot Trial will continue to be closely monitored, with key milestones including the one-year results from the first ten patients expected by the end of this year, followed by the 12- and 24-month results from all 20 patients. The Pivotal Trial will aim to demonstrate the clinical benefits of COPLA® in a randomised trial that is designed to show superiority over current surgical standard treatments and will serve as a cornerstone for market authorisations in the US and EU. Patient recruitment is scheduled to begin in the first half of 2025, and Askel has appointed Dr. Konrad Slynarski (MD) as the Coordinating Principal Investigator. Dr. Slynarski is a distinguished member of the International Cartilage Regeneration and Joint Preservation Society (ICRS) as well as several other sports medicine and orthopedic societies. He is also a member of the Organising and Scientific Committees for the Joint Preservation Congress in Warsaw.
The company announced the issuance of its first patent for COPLA® technology in April this year. The patent was validated as a Unitary Patent, which covers 17 EU-countries. In addition to this, the company has also extended its patent coverage to key markets including the United Kingdom, Spain, and Switzerland. This comprehensive approach ensures that Askel Healthcare’s innovative technology is safeguarded in a total of 20 countries in Europe, laying a solid foundation for international growth and market penetration.
